Commissure Attachments for Prosthetic Heart Valves

Simplified hybrid heart valve design that allows easier implantation and reduced manufacturing time compared to existing hybrid valves. The design features a collapsible expandable frame with limited compression that attaches to a non-expandable valve member. The frame has a collapsible outflow end that can be compressed for delivery, then expands in place during implantation. This allows a larger expanded diameter for physiological functioning, while limiting compression to prevent over-collapsing. The frame integrates commissure posts for the valve leaflets. The valve member can be a pre-assembled valve or separate leaflets. The collapsible frame simplifies assembly compared to prior hybrid valves with both expandable and non-expandable components.

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Valve prosthesis for heart valve replacement that allows secure anchoring of the prosthesis to the native valve tissue without bypassing the chordae tendineae. The prosthesis has a stepwise clamping mechanism with a first clamping member that reaches the valve leaflet and a second clamping member that extends from the first member. This allows the second clamping member to fully surround the leaflet and chordae when released, providing better anchoring compared to bypassing the chordae. The clamping members are also released in a stepwise reversible manner to avoid blocking the valve annulus during deployment.

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Collapsible prosthetic heart valve with an annular frame and leaflets that can be delivered through small catheters for transcatheter valve replacement. The frame has inwardly extending commissure attachment posts to support the leaflet commissures. This prevents leaflet-frame contact during valve operation. The collapsible frame allows compact delivery through narrow catheters. The leaflets are secured to the posts and open widely to allow blood flow. The inward commissure posts clamp the leaflets to prevent abrasion against the frame.

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Prosthetic heart valve design with a locking mechanism to secure the leaflet assembly in place during assembly and use. The leaflet assembly is made by coupling together adjacent leaflet tabs to form commissure tab assemblies. These assemblies are inserted into commissure windows of the frame. Wedge members can be inserted between the tabs or into the windows beforehand to prevent radial movement of the assembly. This simplifies assembly and reduces stitching compared to attaching the tabs directly to the frame. The wedges lock the commissure tab assembly in place in the window.

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Securing a prosthetic heart valve at a native valve like the mitral valve using an expandable anchor device that is separately implanted before the prosthetic valve. The anchor device has a lower portion in the ventricle with leaflet clamping sections and upstanding posts, and an upper portion in the atrium. It is advanced to the native valve, expanded, and positioned with the posts at the commissures. Then the prosthetic valve is advanced and expanded to compress the native leaflets against the clamping sections. This provides a clamping force to hold the prosthetic valve in place.

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Delivery system for implanting prosthetic heart valves with active commissure alignment capability. The delivery device allows controlled rotation of the prosthetic valve inside the delivery sheath to align the commissures with the native valve. This is achieved through features like inner shaft rotation, outer shaft fixed rotation, and torsion springs. The prosthetic valve rotates relative to the outer shaft as the user turns a handle, allowing commissure alignment. The inner shaft is coupled to the handle actuator. The outer shaft has fixed rotation points. Torsion springs or pressure chambers between the shafts resist valve rotation until turned past alignment. This enables the user to actively align the prosthetic commissures with the native valve during implantation.

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Radially collapsible frame for prosthetic heart valves with improved anchoring and reduced wear compared to existing frames. The frame has a cell structure connecting commissure attachment regions at the valve outflow end. An overlapping arch extends above the cell structure. This allows the arch to position in a diseased native valve pocket and cells to anchor the frame. The arch avoids friction with the native valve during leaflet motion. The arch and cells also fix the prosthesis without impingement. The frame is made by laser cutting a hollow tube.

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Valve replacement devices for minimally invasive heart valve replacement that can be compressed for delivery through small incisions and expanded in place. The devices have a radially compressible stent and tissue valve components. The stent has commissural posts with tabs attached to the valve leaflets. The valve leaflets are made of thin pericardium tissue. The compact size enables transvascular or transapical delivery. The valve components are secured inside the stent for compression. The valve tabs attach to the stent posts when expanded. The inner skirt wraps the stent conical section and outer skirt extends outside the stent. The compressed device fits in a delivery catheter for implantation.

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Collapsible transcatheter heart valve with a frame design to prevent leaflet abrasion during valve operation. The frame has inwardly extending commissure attachment posts to secure the leaflet commissures. This allows the leaflet moveable portions to be spaced inwardly from the frame inner surface when open, protecting them from contact. This prevents premature wear and failure of the leaflets. The compressed commissure attachment posts initially clamp the commissures during implantation but remain deflected inwardly.

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A prosthetic mitral valve designed for minimally invasive implantation that closely matches the native mitral valve geometry. The valve has an expandable frame with flared ventricular and atrial anchors that compress the native tissue. The frame has slots for the leaflets to attach. Commissure plates with sutures secure the leaflet arms. Retention hooks on the ventricular anchor prevent dislodging. The frame self-expands to the implant size. The leaflets have protective covers.

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Prosthetic heart valve design with reduced stress on the leaflets to improve durability. The valve has a collapsible and expandable stent with features that indirectly attach the leaflets to reduce stress compared to directly attaching them. The attachment features are rectangular structures with a central aperture. A fabric is folded over the top strut and sutured through the aperture to connect the inner and outer layers. The fabric extends around side struts for some attachment features. This indirect attachment reduces stress on the leaflets during loading compared to direct attachment.

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Anchoring a medical device like a heart valve replacement using tether attachment members that have locking mechanisms to secure the tethers without piercing tissue. The tether attachment members have channels through which the valve tethers pass. A locking pin inside the channel can move to engage the tether and secure it. This allows easy insertion of the tether and then locking it in place without piercing tissue like staples. The locking pins can be actuated to move in and out of the channel. The tether attachment members can be positioned adjacent to puncture sites in the heart wall to anchor the valve tethers and close the punctures.

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A lightweight, single-piece device for fixing cardiac valve leaflets to treat regurgitation. The device has a biased, closed configuration where tissue engaging surfaces are held adjacent by a force sufficient to grasp leaflets. A delivery tool with spreaders can translate the surfaces between open and closed to capture leaflets. The single-piece design reduces weight and components compared to multi-part devices. The device's shape memory bias force enables secure leaflet fixation without excess weight.

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Tissue anchors for cardiac valve repair that have features for easier delivery, improved anchoring, and visual confirmation of successful implantation. The anchors have shaped eyelets for sliding along wires/sutures during delivery, spacers to compress during implantation, and heads that deform to indicate successful anchoring. The spacers prevent excess wire/suture from protruding and the heads compress against the tissue. The eyelets have tapered sections to slide smoothly along wires/sutures when aligned and orthogonal. The anchors can also have locking mechanisms to secure the sutures after annuloplasty.

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A suture lock assembly for securing sutures during implantation of medical devices like prosthetic heart valves. The assembly has a tensioner that can rotate to gather suture length. It also has a quick release mechanism to lock and unlock the suture end. This allows sutures to be securely tightened, then released for easy removal after device implantation. The assembly is integrated into the delivery apparatus for the implantable device.

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Anchoring device and system for securing a prosthetic heart valve to tissue without the need for sutures. The anchoring device consists of a surgical anchor with a distal tip to pierce tissue and a proximal head to engage the valve. The anchor is deployed through the valve into adjacent tissue, then the head is brought into contact with the valve to approximate it. Tension in the anchor pulls the valve into place. The system uses a deployment device with rotating arms to drive anchors into tissue. The valve itself has malleable inflow cells, rigid annular cells, and rigid leaflet posts to allow tissue ingrowth.

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Device and method for securing a prosthetic heart valve at a native valve like the mitral valve. The device is an expandable anchor with a lower portion in the ventricle and an upper portion in the atrium. The lower portion clamps the leaflets using protrusions. The upper portion supports the atrium. The prosthetic valve is inserted inside the native valve and expanded to clamp against the lower anchor. This fixes the prosthetic valve in place without compressing the native annulus.

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Expandable prosthetic heart valves that better secure to and remodel the valve annulus to improve performance compared to traditional expandable valves. The valves have anchors that engage surrounding tissue when deployed. These anchors can be separate components or integrated into the valve body. They pull inward during valve expansion to constrict the annulus. This reduces the valve size and pulls the annulus tissue inward as well. The anchors can also be constricted separately using external mechanisms. The valve construction allows treating large annuli with fewer valve sizes and reducing device profile.

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Prosthetic heart valves with improved sealing and anchoring to native valves, particularly for minimally invasive implantation. The valves have features like radial flanges, conformable structures, offset sealing sections, and distal anchor configurations to better match irregular native valves and promote sealing and anchoring. They can also have docking mechanisms to simplify implantation. The valves can be delivered through smaller incisions compared to open heart surgery.

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A locking ferrule with a one-way locking mechanism for tensionable knotless cardiac valve procedures. The ferrule has a cannulation with locking barbs that engage a suture after it is passed through. This allows tensioning the suture in one direction and then locking it in place to prevent movement. It enables securing sutures in cardiac valve procedures without knots for tensioning and stabilization. The ferrule can be loaded with a suture and then moved to the valve tissue where it is tensioned and locked in place.

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Minimally invasive procedure to reshape heart valves and subvalvular tissue using a multi-opening guide catheter. The catheter has multiple openings spaced closely together. An anchor with a tether attaches to the heart tissue through one opening. The catheter then releases the tether to secure the anchor in place. This allows multiple anchors to be delivered and positioned through the closely spaced openings. The catheter holds the tethers during delivery and release. This stabilizes the device during implantation compared to openings far apart where the tethers would swing freely.

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A low profile, balloon expandable artificial prosthetic aortic valve for transcatheter implantation that aims to address some limitations of current transcatheter aortic valve replacement (TAVR) devices. The valve design involves a cylindrical frame with a cuff made of a polymer material that is integrally attached to the frame. The cuff covers the frame both inside and outside in the supporting section. This provides a one-piece construction that eliminates the need for separate leaflets, commissure masts, or sewing steps to attach the leaflets to the frame. It aims to simplify the valve design, reduce manufacturing time and cost, and potentially improve durability compared to using separate leaflets and sewing them to the frame.

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A prosthetic heart valve system with reduced stress on the leaflets during operation to improve durability. The valve system has a unique attachment method between the leaflets, cuffs, stents, buffers, and commissure features to reduce stresses in the leaflet material. This involves folding the leaflet attachment regions adjacent to the commissure attachment features to allow stress reduction, redistribution, and dampening during valve operation. This helps prevent leaflet tearing and failure over time due to the high stresses encountered during valve opening and closing.

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Expandable prosthetic heart valves with outer skirts that reduce push forces during implantation through delivery sheaths. The skirts have axially extending portions covering commissures at the valve outflow end. This provides a smoother surface at the outflow for easier delivery through vessels. The skirts also seal against native tissue upon expansion. The skirts can have features like tapered extensions, stitch lines, and wrapping around inflow struts to facilitate delivery and reduce paravalvular leakage.

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Reducing stress on leaflets of transcatheter heart valves to improve durability and longevity by allowing deflection at attachment points. The technique involves using patches, billowing patches, or flexible intermediate materials between the leaflets, cuffs, and stents to enable localized movement of the leaflets during valve operation. This reduces stress concentrations in high-stress regions like commissures, preventing leaflet damage and failure over time.

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Heart valve prosthesis to reduce thrombus formation by using a capsule connected to the stent that expands and collapses around the commissure points between the artificial valve leaflets. The capsule has a gap facing the outflow end. When the valve opens, the capsule is collapsed, allowing full blood flow. When the valve closes, the capsule expands around the leaflet commissures to seal, preventing blood flow stagnation and thrombus formation.

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Manufacturing prosthetic heart valve that reduces the strain placed on the valve assembly without affecting the prosthetic heart valve's ability to collapse. The valve includes a commissure attachment feature that extends in the medial direction of a stent for coupling a valve assembly to the stent.

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Prosthetic valves that can be delivered through a catheter and implanted over native valves to replace them. The prosthetic valve has a heat-shrink sleeve over the commissural support members to reduce wear on the leaflets and improve durability. The heat-shrink sleeves are shrunk tightly over the support members before attaching the leaflets. This prevents contact between the leaflets and frame during opening, reducing wear. The heat-shrink sleeves can be made from a polymer like polyvinyl chloride.

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A prosthetic tricuspid valve that can be implanted in a native tricuspid valve without direct attachment to the annulus or chordae tendineae. The valve has asymmetrical support structures that grasp the native leaflets and allow the prosthetic valve to move with the native valve during the cardiac cycle. This biodynamic design preserves native annulus motion and prevents issues like heart block. The valve has leaflets, covers, and arms that attach to the native leaflets and surround the native annulus.

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Implanting a prosthetic heart valve in a patient's body using an open configuration. The implant includes a metal frame, two or more polyethylene terephthalate (PET) or natural tissue (e.g., pericardial tissue) skirts, and an implantable prosthetic heart valve coupled to the frame via commissure tab assemblies.

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Valve prosthesis for implantation in the human body, such as heart valves, made from woven ligament tissue that provides mechanical stability and biocompatibility. The valve leaflets are formed from ligament tissues with warp threads tangential to the valve base and weft threads axial. The weft threads at one edge reverse orientation to create a free leaflet edge. The tissue structure allows colonization by cells for tissue engineering applications. The valve stent has commissure struts and the ligament tissues are wrapped around it, sewn, or glued to fix. The tissue can be stabilized further with additional fabrics or sutures.

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Prosthetic heart valves and delivery methods to seal native heart valves and reduce regurgitation. The prosthetic valves have bodies that extend the length and width of the native leaflets, filling gaps and promoting coaptation. They can be secured with sutures or anchors. Delivery involves threading a catheter through the heart, extending a rail through the leaflet, and pulling it back to form a loop. The prosthetic valve is then advanced through the rail to the leaflet. This allows implanting the valve without enlarging the annulus. The rail can also be snared and retracted through the catheter.

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Prosthetic heart valve with adjustable commissure supports that allow the valve to be expanded to a wide range of diameters while maintaining proper leaflet coaptation. The commissure supports have adjustable arms that can be rotated or twisted to adjust the tension on the attached leaflets. This allows customizing the valve diameter for each patient by adjusting the commissure support arms to match the expansion diameter of the valve frame. A delivery assembly allows in-situ adjustment of the commissure supports after valve implantation.

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Prosthetic heart valve leaflet assembly with asymmetrical leaflets and commissure assembly configurations to improve durability and reduce wear compared to conventional symmetrical leaflet designs. The leaflets have tabs with vertical extensions that fold over adjacent leaflet tabs to form commissures.

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A biomechanically anchored artificial tricuspid valve that improves function and reduces complications compared to conventional replacement valves. The valve is designed to biomechanically secure to the native tricuspid valve leaflets instead of attaching to the annulus. This allows the prosthetic valve to move axially within the native valve during the cardiac cycle. The anchoring reduces motion differences compared to the native valve, avoiding conduction blockages. The valve also has asymmetric support structures, pleated atrium covers, and leaflets that contact each other to prevent leakage. The biomechanical anchoring reduces blood flow obstruction and thrombus formation compared to rigidly fixing the prosthetic valve to the annulus.

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Heart valve prosthesis with a unique leaflet arrangement and connectivity between the valve and anchor components that allows separate replacement of the valve without removing the anchor. The valve has asymmetric leaflets that close the valve orifice in different angles. The leaflets are fixed to a conical support structure. The anchor has a skirt that folds around it and connects to the valve via seams. The valve and anchor are separated by the skirt folds, allowing valve replacement without anchor removal.

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Valve holder assembly for minimally invasive heart valve replacement surgeries that reduces suture looping and improves deployment consistency while also minimizing force required to remove the holder after implantation. The holder has a rotating mechanism to bend the commissure posts before implantation, with hard stops to prevent over-bending. The suture routing around the commissure posts is improved to reduce contact with the valve leaflets and force needed to remove the holder. The holder also has features like recessed suture guides and a ledge to hide the routing.

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Prosthetic heart valve with restraining posts that prevent unwanted rotation or movement of the leaflet commissure assembly during crimping and expansion of the valve. The posts have protrusions that engage the commissure tabs to limit axial motion. The commissure tabs wrap around the posts in opposing directions. This provides a secure and self-aligning attachment of the leaflets to the frame, reducing the risk of detachment or misalignment during deployment.

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Collapsible prosthetic heart valve that can be repositioned during deployment to improve implantation and reduce leakage. The valve has a stent with commissure features that have eyelets for distributing leaflet load. The leaflets attach to these eyelets. This allows the leaflets to move relative to the commissures when the valve is collapsed and deployed, allowing better adaptation to irregular native valve shapes. The eyelets also disperse load to prevent tearing.

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A prosthetic heart valve design that improves durability of the leaflet attachment points, particularly at the commissures, by using a unique stent configuration. The stent has a commissure attachment feature with an opening surrounded by a frame. The skirt is connected to the frame at the commissure feature. The leaflets are attached both through the opening and outside of it. This provides redundant leaflet fixation at the commissures, reducing stress concentration and improving durability compared to traditional stent designs where the skirt attaches directly to the stent at the commissures.

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Prosthetic heart valve having increased effective flow area for a given valve size, with wireform and flexible leaflet structure modifications. The valve has an undulating wireform/stent covered in cloth with cusps and commissures. Flexible leaflets attach between the cusps and around the commissures. To increase orifice area, the leaflets extend over the cusps and/or commissures of the wireform. This allows larger leaflet coaptation area compared to traditional heart valves, increasing effective flow area for a given valve size.

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Prosthetic heart valve with modified structure to reduce pressure drop across the valve. The valve has a support frame with undulating inflow cusps and outflow commissure posts that angle outward to widen the outflow orifice. The flexible leaflets attach to the cusps and coapt in the middle. When the valve opens, the leaflets spread outward to provide an outflow orifice area at least as large as the maximum flow orifice area. This prevents flow restriction. The angled commissures provide a larger exit orifice than entrance orifice to induce laminar flow and reduce pressure drop.

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Assembling commissures for prosthetic heart valves using folded leaflet tabs to reduce wear and simplify assembly compared to sutures. The method involves folding the commissure tabs of adjacent leaflets into overlapping layers, with the outer edges folded inward. These folded tabs are then joined together and attached to the valve frame using separate fasteners. The folded tabs are positioned tangential to the valve circumference outside the leaflet body. This allows the leaflets to move independently during valve operation while the commissures are fixed. The folded tabs provide a secure, wear-resistant commissure connection without stitching the leaflets directly to the frame.

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A prosthetic heart valve design with improved leaflet attachment and sealing at the commissures. The leaflets are assembled with overlapping folds at the commissure tabs that are secured to an attachment member. The folded tabs are sandwiched between the valve frame and the attachment member. This avoids vertical folds that weaken the commissure. The attachment member is directly attached to the frame supports or a separate element. This improves durability and sealing compared to stitching. The overlapping folds allow secure attachment with fewer stitches.

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Prosthetic heart valve with improved leaflet assembly method that simplifies attachment to the valve frame. The leaflet assembly has multiple leaflets joined at their half-commissure portions. This allows separate leaflet assembly before attaching to the frame. The half-commissure portions are formed by folding skirt lugs around leaflet lugs and stitching. Adjacent half-commissures are then joined to form the full commissure. This simplifies leaflet assembly versus attaching each leaflet to a continuous skirt around the frame.

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Holder to facilitate implantation of mitral prosthetic heart valves. The holder attaches to the inflow end of the valve and includes a mechanism to flex the commissure posts inward to prevent suture looping during deployment. It also has a handle that angles outward for better visualization and manipulation. The holder can tension sutures connected to the valve to constrict the commissures.

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Prosthetic heart valve with reduced pressure gradient and regurgitation for improved hemodynamics compared to conventional bioprosthetic valves. The valve has a unique support frame with angled commissure posts that widens the outflow orifice area when open. The flexible leaflets expand without creating shelves. The leaflets attach with conforming cusps and coapt to prevent regurgitation. The frame and leaflet shapes minimize pressure drop and regurgitation.

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A collapsible and expandable prosthetic heart valve with an anchoring tether to stabilize the valve within the native annulus without extending into the ventricle. The valve has an expandable stent, valve assembly, and tether connector. The tether is attached to the connector and extends through the valve and heart wall to an external location. An apical pad is secured to the tether outside the heart. Tightening the tether anchors the valve in place without obstructing blood flow.

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Prosthetic heart valve with a unique leaflet attachment method that reduces thrombus formation and eliminates the need for fabric components. The leaflets are attached to the frame using a primary suture threaded through the cusp end and a secondary suture that wraps around the struts and forms self-tightening constructs. The primary suture tracks the cusp edge shape. This allows direct attachment of the leaflets to the frame struts without intermediate fabric layers that can promote tissue ingrowth. The secondary suture forms loops and knots around the struts to secure the leaflets.

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Heart valve prosthesis with flexible leaflet and skirt components that can adapt to specific locations like the aorta. The prosthesis has a valve member with flexible leaflets and a valvular support structure, and an anchoring member with a flexible skirt. The leaflets and skirt can be made from materials like pericardium or bacterial cellulose. The skirt tapers conically like the valve member. This allows the prosthesis to conform to aortic geometry during implantation. The skirt and leaflets can be connected by sewing to prevent displacement. The skirt folds around the anchoring structure for fixation. A releasable connection between the valve and anchoring allows prosthesis replacement without removing the entire implant.

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